Trials / Completed
CompletedNCT02950168
Edoxaban Management in Diagnostic and Therapeutic Procedures
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 1,197 (actual)
- Sponsor
- Daiichi Sankyo · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Patients receiving Novel Oral Anticoagulation (NOACs) undergo diagnostic and therapeutic procedures at a rate of 10% per year. Short half-lives and rapid onset of action allow for short periods of NOAC interruption without heparin bridging. There is only minimal information on the peri-procedural usage pattern of edoxaban and the related outcome data currently available. Therefore, further real-world clinical data on the peri-procedural usage pattern of edoxaban within any diagnostic or interventional procedure in patients with non-valvular atrial fibrillation (NVAF) or venous thromboembolism (VTE) will be collected in this registry.
Detailed description
Patients treated with edoxaban and with a planned or unplanned diagnostic or interventional procedure will be enrolled in this study in order to evaluate the peri-procedural dosing of edoxaban in patients with diagnostic or therapeutic procedures and collect details of the type diagnostic or therapeutic procedures. Patients from 7 different countries and care settings (primary care, secondary care, and different medical specialties) will be enrolled. The study will last until approximately 2000 procedures have been documented, e.g., until about 2000 participants are enrolled, which is expected to take approximately 2.5 years. Any relevant diagnostic or interventional procedure reported will be collected and documented in the electronic case report form (eCRF). Patients will be followed for 30 days after the procedure.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Edoxaban | Edoxaban according to Summary of Product Characteristic (SMPC) |
Timeline
- Start date
- 2016-11-01
- Primary completion
- 2018-07-26
- Completion
- 2018-07-26
- First posted
- 2016-10-31
- Last updated
- 2020-02-05
Source: ClinicalTrials.gov record NCT02950168. Inclusion in this directory is not an endorsement.